Previous research has suggested that patients with classical Hodgkin lymphoma who are refractory to or relapse after first-line therapy may be more likely to be cured after receiving second-line salvage chemotherapy followed by autologous stem cell transplantation (ASCT) than after receiving standard-dose chemotherapy.1,2 High complete remission rates prior to ASCT have been shown to predict better long-term outcomes for patients with the condition.3 Researchers have investigated a number of combination therapy regimens as induction regimens prior to ASCT for refractory to or relapsed lymphoma, yielding pre-ASCT CR rates ranging from 20% to 54% and overall response rates (ORRs) of 60% to 80%.4

A prospective multicenter single-arm phase 2 study also indicated that the combination of bendamustine, gemcitabine, and vinorelbine (BEGEV) as second-line chemotherapy before ASCT, in 59 patients with relapsed/refractory (R/R) classical Hodgkin lymphoma, resulted in a CR of 73% and ORR of 83%.5

Now, updated 5-year results from that same study have confirmed the benefits, showing a CR rate of 75% and ORR of 83%.6 But experts cautioned that a randomized trial would be needed to determine whether the regimen is superior to other treatments.

The update[d] 5-year results ofBEGEV (bendamustine, gemcitabine, vinorelbine) followed by autologous stem celltransplantation in patients with Hodgkin disease refractory or relapsing tofirst-line therapy confirm the significant data in terms of CR rate (75%) aswell as PFS (59%) and overall survival (78%), lead study author ArmandoSantoro, MD, director of the Cancer Center at Humanitas Research Hospital,Milan, said in an email.

The trial involved 27 patientswith classical Hodgkin lymphoma who were refractory to and 32 patients whorelapsed after receiving 1 line of chemotherapy. The patients received 800 mg/mgemcitabine on days 1 and 4, 20 mg/ m vinorelbine on day 1, and 90 mg/mbendamustine on days 2 and 3. The patients received 100 mg prednisolone on days1 to 4. They were given 4 cycles of BEGEV every 21 days.

Those patients who experiencedcomplete response or partial response after completing the 4 cycles receivedmyeloablative therapy with carmustine, etoposide, cytarabine and melphalan orfotemustine, etoposide, cytarabine and melphalan, which preceded the reinfusionof CD341 cells.

The researchers evaluated diseaseresponses before and after the fourth BEGEV cycle using computed tomography and18F-fluorodeoxyglucosepositron emission tomography scans accordingto the International Working Group response criteria.

The treatment prompted CR in 44patients (75%) and partial response (PR) in 5 (8%), yielding an OR of 83%. Theauthors noted that the CR rate was higher than the 54% CR rate previouslyreported for the ifosfamide, gemcitabine, vinorelbine, and prednisolone (IGEV)regimen as well as other second-line chemotherapy-based salvage regimens.

Of 49 patients who responded toBEGEV and were eligible for ASCT, 43 ended up receiving transplants. After 5years following BEGEV treatment, the PFS for all series was 59% and OS was 78%.More than 90% of patients were at high risk for relapse post-ASCT. At 5 years,33 patients who received transplants experienced continuous CR, 7 relapsed, and3 died due to unrelated factors that included pneumonia, infection, andmultiorgan failure.

Excerpt from:
BEGEV Salvage Regimen Linked to High Complete Remission Rates - Cancer Therapy Advisor